MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM; MDS

Model Number MT20649

Device Problems No Audible Alarm (1019); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Crushing Injury (1797); Hyperglycemia (1905); Hypoglycemia (1912); Laceration(s) (1946); Paresis (1998); Loss of consciousness (2418)

Event Date 02/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia and loss of consciousness.

Event Description

Patient contacted dexcom on (b)(6) 2016 to report an adverse event that occurred on (b)(6) 2016.Patient stated that they blacked out at the wheel, due to low blood sugar, resulting in a car accident.Patient was not really conscious for almost a week, following the accident.There was no alleged device malfunction.No additional event or patient information was provided.

Manufacturer Narrative

(b)(4) voluntary medwatch report number mw5064212.(b)(4).

Event Description

Subsequent to the initial mdr, additional information was received on 09/08/2016 via voluntary medwatch report.While driving, patient's blood sugar dropped and the receiver did not alert him.Patient blacked out at the wheel and it resulted into a head on accident into another vehicle.Patient's blood glucose was not checked at the scene of the accident.Patient believes that his fight or flight resulted in raising his blood sugars to high levels as found when checked in the trauma unit approximately one hour after the accident.Accident resulted in limited use of right hand, crushed left hip, cracked knee cap, crushed/broken right wrist and other wounds with no lasting effect.Patient reported to still be pulling out glass out of arms.Patient reported that the device is no longer working after the accident.No further patient or event information is available.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 5629636
• MDR Text Key: 44330747
• Report Number: 3004753838-2016-02860
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000064
• UDI-Public: (01)00386270000064(241)MT20649(10)5195443(17)NA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649
• Device Catalogue Number: STK-GL-001
• Device Lot Number: 5195443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR